IRB Connection HSO Newsletter

 
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2015

December

  • HawkIRB Phase II Changes: Central and External IRB Models
  • Developing Your Data Management Plan
  • HawkIRB Hints: Breaking Down the Details of Risks

October

  • Changes to the HawkIRB Application: Phase 1
  • Underrepsentation in Clinical Trials: The Black Experience
  • HawkIRB Hints: YOU Can Prevent Reportable Events!

August

  • Back to School Special: Faculty Advisor Responsibilities
  • Attention Biomedical Researchers: New Type of PRMC Notice
  • HawkIRB Hints: Finding Your Way in HawkIRB

June

  • It’s OK to Delegate, but Remember… It’s Still Your Study!
  • How Do I…?  FAQ Page Links
  • HawkIRB Hints: How Do You Attach a Revised Document?

April

  • The Tattletale IRB
  • IRB Compliance Staff to attend FDA Audits
  • HawkIRB Hints: Best Kept Secret

February

  • "I didn't think it was Human Subjects Research because..."
  • UI policy on Mandatory Reporting of Physical and Sexual Abuse of Children: The Research Perspective
  • Conflict of Interest in Research-Implications for Investigators

2014

December

  • External IRBs incorporated into HawkIRB
  • Financial Interest Disclosure Reporting
  • News Flash

October

  • Financial Conflict of Interest in Research
  • Upcoming AAHRPP Site Visit
  • Subjects Who Are Lost to Follow-up
  • News Flash: HSO Interim Director appointment and staff departures

September

  • Keeping Current on International Research Regulations
  • Tips to Improve your Informed Consent Document
  • Mainline Questions: HawkIRB Workflow

August

  • Facebook's Controversial Sociological Study
  • A personal Note from the HSO director
  • Need help with HawkIRB? Herky Hints: Oops, I Made this Draft... Now What?
  • New Positions filled in the Human Subjects Office!

July

  • Research Misconduct, Prevention Strategies and More
  • Changes in IRB Determinations for Studies that Access PHI for Recruitment
  • Did You Know? – HSO Presentations
  • Who Should Be a Research Team Member?
  • Try Your Hand at Being an IRB Chair

June

  • A More Flexible IRB on the Horizon
  • Tips to Protect and Secure Information When Using Mobile Devices
  • News Flash: Relocation of the Conflict of Interest in Research Program
  • Need help with HawkIRB?  Herky Hints: Assurance Document

May

  • IRB Review of Qualitative Research – Just Jumping Through the Hoops?
  • A Change in Your Summer Plans? - Let us Know!
  • News Flash: HSO Staff Farewell
  • Need help with HawkIRB? Herky Hints: Dealing with HawkIRB email notifications

April - Research with Children Special Edition

  • Risk and IRB Review
  • Assent
  • Parental Permission  
  • Applicable Regulatory Definitions
  •  HawkIRB: Procedures for Obtaining Consent and Assent
  • Pregnancy in a Minor Subject Population

April

  • Describing Risk to Research Participants
  • Disclosing the Probability and Magnitude of Physical Risk
  • What We Did Last Month...Submitted an application for AAHRPP Re-Accreditation
  •  News Flash: Changes with HawkIRB and the CRU
  • This month in Human Subjects Protection History: The Belmont Report

March

  • Additional Requirements for DoD Research
  • Where is this CITI of which you speak, and what does it have to do with me?
  • Spring Break Reminder (submit your HawkIRB application/HSRD)
  • IRB Policy Revision: Revised Guidelines Regarding Payment and Compensation
  • What’s that Mean?: Certified IRB Professional

February

  • New Compliance Monitoring Programs Coming to a Study Near You​
  • News Flash: HSO New Hours of Operation
  • IRB Policy Revision: Inclusion of Compensation Amount in Recruitment Materials
  • IRB Policy Reminder: Cold-Calling of Potential Subjects as a Recruitment Method​

January - Reportable Events Special Edition (IRB-01/03) 
January - Reportable Events Special Edition (IRB-02) 

  • What are Reportable Events?
  • Serious Adverse Drug Events (IRB-01/03)
  •  Serious Adverse Device Effect (IRB-01/03)
  •  Reportable Events Q&A: Why do I need to submit REFs?
  • Receipt of New Information
  • Unanticipated Problems Involving Risks to Subjects or Others
  • Noncompliance
  • Preventing Reportable Events

January

  • Letter from the Editor
  •  Should I Submit a New Project Application or a Modification?
  • News Flash: Andy Bertolatus' retirement announcement
  • Back to School Reminder: Submit your HawkIRB Application

2013

December

  • Why is My Study Going to the Full Board?
  • Come to the Dark Side, we have cookies! (Working for the HSO)
  • What's that Mean?: Human Subjects Research Acronyms
  •  HawkIRB: How Do I Use the Inbox Filter?

November

  • The Informed Consent Process
  • Mainline Questions: Flavors of Waivers
  • Use of Short Form Consent Document for Non-English Speaking Subjects
  • Obtaining Required Signatures on the Informed Consent Document

October

  • Coercion and Undue Influence: What is the difference?
  • Mainline Questions: Alphabet Soup (HSO vs. IRB)
  • HawkIRB: How Do I Use the Delegate Permission System?
  • IRB Policy Reminder: Requirements for Completion of Optional Agreements

September

  • Mainline Questions: What does Exempt mean?
  • The Mailed Consent Process: What to do if there are errors?
  • Back to School: Human subjects research in the classroom
  • News Flash: Course-Related Student Project Policy Revision
  • IRB Policy Reminder: UI Students as Research Subjects

August

  • Enrolling Minors: What Happens When They Age Up?
  • HIPPA/HITECH Act Omnibus Final Rule
  • Human Subjects Research Data and Sample Identification Terms
  • IRB Policy Reminder: Case Report Forms (CRFs) Should not be attached to the HawkIRB Application
  • Have an idea for IRB Connection?

July- Genetic Research Special Edition

  • Federal Regulations and Guidance
  • Genetic Information Nondiscrimination Act (GINA)
  • Is it Genetic Research?
  • Incidental Findings

July

  • Top 5 Monitoring Findings of 2012
  • Mainline Questions: Do I have to fill out an IRB application?
  • HawkIRB: How do I find my Approval Memo?
  • Get to Know: The HSO Exec. Director and UI Institutional Official
  • News Flash: My Research Portal

June

  • Greetings from the HSO: Mainline Questions
  • New FDA Rule: Children in Clinical Investigations
  • IRB Policy: Compensation in Recruitment Materials
  • Get to Know: The Education and Compliance Staff

May

  • Plain Language Facilitating Subjects Understanding
  • Revisions to the Declaration of Helsinki
  • IRB Policy Reminder: Recording Additional Information on the Informed Consent Document
  • Issues to Consider when a PI leaves the UI
  • Get to Know: The IRB-02 Staff